Gabapentin for the Treatment of Tinnitus - Full Text View

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00317850

Purpose

The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.

Condition	Intervention	Phase
Tinnitus	Drug: Gabapentin (Neurontin)	Phase II Phase III

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:

Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary Outcome Measures:

Beck Depression Inventory Score from Baseline to Week 8
Brief Symptom Inventory Score from Baseline to Week 8
Epworth Sleepiness Scale Score from Baseline to Week 8

Estimated Enrollment:	160
Study Start Date:	April 2004
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adults, between the ages of 18 and 70
Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month’s duration or greater
Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.

Exclusion Criteria:

The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled.
Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance.
Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
Patients with any serious or unstable medical or psychiatric condition.
Patients whose ability to give informed consent is in question.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317850

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Jay F Piccirillo, MD

Washington University School of Medicine

More Information

Clinical Outcomes Research Office at the Washington University School of Medicine This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7.

Study ID Numbers:	R01 DC006253-01
Study First Received:	April 21, 2006
Last Updated:	May 12, 2006
ClinicalTrials.gov Identifier:	NCT00317850
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Excitatory Amino Acids
Calcium, Dietary
Signs and Symptoms
Sensation Disorders
Hearing Disorders

Otorhinolaryngologic Diseases
Gabapentin
Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009